DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 February 2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0302997 (“Gardner”) in view of U.S. Publication No. 2010/0049170 (“Soloman”) and U.S. Publication No. 2010/0050351 (“Colantonio”).
Regarding Claim 1, Gardner discloses a cap (110) configured to engage a male connector (12, 18, 22), the cap comprising:
a housing (128) comprising an open first end (not labeled – see Fig. 5, i.e. the open end receiving 18), a second end (not labeled – see Fig. 5, i.e. the closed end opposite the first end), and at least one sidewall extending between the first end and the second end (not labeled – see Fig. 5);
an outer absorbent support (111 – Par. 47) disposed in the housing defining a recess (not labeled – see Fig. 5, i.e. the empty space between 111);
a socket (134) disposed in the recess of the outer absorbent support, the socket having threaded structures (not labeled – see Fig. 5) to engage the male connector for retaining the male connector within the housing (see Fig. 5).
In the embodiment depicted in Figure 5 Gardner fails to disclose an inner support disposed in the socket and configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap and a seal disposed in the socket overt the inner absorbent support configured to seal an open end of the male connector thereby preventing the cleaning solution from entering a lumen of the male connector.
In other embodiments (See 210, 310, 510) Gardner discloses various inner supports (211, 311, 511) which may be configured as either an absorbent support (211 – Par. 49) configured to store and release an antiseptic solution to ensure adequate disinfecting of the male connector or plug and seal (311, 511 – Par. 56, 63) the central lumen of the male connector to prevent the antiseptic cleaning solution from entering the lumen of the male connector and configurations wherein the inner socket (730) is provided with an additional source of cleaning agent (725) provided on an absorbent support. However, in no embodiment does Gardner combine these two concepts to ensure disinfection of the terminal, exterior surface of the male connector while sealing the lumen to prevent migration into the interior of the male connector.
However, such concepts are known to the prior art. For example, Solomon discloses a related socket (2252) that is configured to disinfect the post (2020) of a male connector inserted therein with particularly focus on disinfecting the terminal exterior surface (2021) while sealing the lumen of the male connector to prevent the migration of cleaning solution into the interior of the connector (Par. 190, 196). Solomon discloses an inner absorbent support (2270 – Par. 204) disposed in the socket and configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap and a seal (2390 – Par. 197) disposed in the socket over the inner absorbent support and configured to seal an open end of the male connector to thereby prevent the cleaning solution from entering the lumen of the male connector.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the socket of embodiment (110) of Gardner with an inner absorbent support and seal disposed therein, as disclosed by Solomon, in order to permit complete and proper disinfection of the entire exterior surfaces of the male connector while ensuring that the solution does not migrate into the interior of the male connector and ensuring that a sufficient volume of cleaning agent is provided to ensure full wetting and coverage of the received connector.
Gardner, as modified, discloses the invention substantially as claimed except that for disclosing that the “outer absorbent support [is] configured to compress axially when the male connector is inserted into the housing”. Gardner does disclose that the cap material may be compressible in order to assist in releasing antiseptics agents to the connector upon insertion (Par. 37), but fails to disclose any “axial” compression of the outer absorbent support section. However, Examiner first notes that this “configured to” language is a product of not only the specific arrangement of the outer absorbent support, but also requires consideration as to the dimensions of the corresponding male connector, the male connector not being a positively required part of the workpiece of Claim 1. Specifically, within the context of Claim 1, the cap of Gardner is not limited to pairing with the specific, illustrated connector (12), but can be paired with any suitable male connector including those of different dimensions. For example, without any further modifications to Gardner the cap can be paired with a male connector which is wider and longer than that illustrated such that a wider peripheral edge of the connector causes some axial compression on the sidewall of the outer absorbent support upon initial insertion AND a longer peripheral edge causes axial compression of the bottom portion of the outer absorbent support upon full receipt of the fitting.
However, should Examiner’s arguments not be found persuasive the following is presented. Colantonio discloses a related cap (10) for a connector (11) wherein the cap includes a similar outer absorbent support (15) disposed within the housing (12) and formed of compressible material such that when the connector is inserted (see Fig. 6) the outer absorbent support is configured to compress axially (see Fig. 5 and 6 in series) in order to allow an indicator (18) provided at the rim of the housing to be exposed, thereby indicating that the cap has been used and should not be reused (Par. 34). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the cap and connector of modified Gardner to axially compress upon insertion of the connector, as disclosed by Colantonio, in order to allow axially compression of the outer support to result in permanent deformation of the support to thereby reveal a use indicator.
Furthermore, it will be understood that axial compression of the outer absorbent support, particularly the end wall of the support, responsive to insertion of the connector of Gardner and the distal end of the connector making compressive contact therewith, would be beneficial for helping to release antiseptic agent and cover the entirety of the exposed surfaces of the male connector (see Colantino – Par. 14, 36, Fig. 6). As such, raising the end wall of the outer support such that it makes compressed contact with the distal face of the connector edge would have been obvious to ensure that ALL exposed surfaces of the connector are brought into cleaning contact with the support.
Regarding Claim 2, Gardner discloses the male connector may comprise a luer stem (22) defining a central lumen (see Fig. 5) and a shield (18) extending about the stem, and wherein the shield of the male luer connector comprises threads (20) on an inner surface of the shield configured to engage corresponding threads of a female luer connector for securing the male connector to the female luer connector (see Fig. 5).
Regarding Claim 3, Gardner discloses when the male connector is engaged to the cap, the luer stem of the male connector is inserted into the socket and an outer surface of the annular shield is in contact with an inner surface of the outer absorbent support (see Fig. 5).
Regarding Claim 4, Gardner discloses when the male connector is engaged to the cap, cleaning solution is exposed to the threads on the inner surface of the annular shield for cleaning and/or disinfecting the threads (see Fig. 5).
Regarding Claim 9, Gardner discloses the recess defined by the outer absorbent support comprises a first portion having a first diameter corresponding to an outer diameter of an annular shield of the male connector and a second portion axially aligned with the first portion having a second diameter corresponding to an outer diameter of the socket (see Fig. 5 – compare with the species that comprises only the socket, e.g. Fig. 1 and 6, with the recess in Fig. 5 defining an inner concentric diameter about the socket and an outer concentric diameter about the side wall).
Regarding Claim 10, Gardner discloses the socket comprises an open first end, a second end, and a sidewall extending between the first end and the second end (see Fig. 5), wherein the threaded structures of the socket further comprises a thread extending radially outward from the sidewall of the socket, the thread configured to engage threads on an inner surface of a shield of the male connector (see Fig. 5).
Regarding Claim 11, Gardner discloses the engagement between the thread of the socket and the threads of the shield of the male connector rotatably secures the male connector within the housing (see Fig. 5).
Regarding Claims 12 and 13, Gardner, as modified by Solomon, discloses the invention substantially as claimed except that the sidewall of the socket comprises at least one opening for permitting solution to pass through the socket to the outer absorbent support – the openings comprising a first slot with a second slot extending axially from the open first end of the socket opposite from the first slot. However, Solomon, in various embodiments discloses that the sidewall of the socket may be configured to incorporate at least one opening (2253) comprising a first slot extending axially from the open first end of the socket and a second slot (Par. 213-214 – re: “one or more slots”) extending axially from the open first end of the socket on an opposite side of the socket from the first slot in order to permit cleaning solution to pass through the socket to the outer absorbent support (see Fig. 46). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide venting slots in the interior surface of the support of modified Gardner, as disclosed by Solomon, in order to ensure maximum distribution of entrained cleaning agents about the various exterior surfaces of a received male connector. Examiner submits that the spacing of multiple vents, to include diametrically opposed configurations is an obvious design choice pursuant to the direction provided by Solomon of duplicating the vents, whereby the ordinary artisan would recognize that diametrically opposed vents would provide greater coverage than vents which both are disposed on one hemisphere of the socket and separated by less than 180 degrees such that the first slot extends axially from the open first end of the socket with a second slot extending axially from the open first end on a side opposite from the first slot.
Regarding Claim 14, Gardner, particularly as modified by Solomon, discloses insertion of the male connector into the socket causes the inner absorbent support to axially compress farther into the socket (see Solomon – Fig. 38, 39), and wherein the axial compression of the inner absorbent support expels the cleaning solution from the inner absorbent support causing the cleaning solution to move through an interior of the socket contacting an outer surface of a stem of the male connector inserted in the socket (see Fig. 39 – Solomon). Additional consideration must also be made to the fact that the instant claim does not positively recite the male connector and the cap of modified Gardner is, within the broad context of the claim, configured to interface with any conceivable geometries of male connectors inclusive those with longer stems, shields, and different sized diameters which will affect how the absorbent portions of the modified cap and compressed and permitted to cause disinfectant to flow about the various surfaces of the male connector.
Regarding Claim 15, Gardner discloses a cleaning solution absorbed by the inner absorbent support, wherein the cleaning solution comprises IPA (Par. 43).
Regarding Claim 16, Gardner, as modified by Solomon, discloses the seal (see 2390 – Solomon) is positioned to permit the cleaning solution expelled from the inner absorbent member to move past the seal towards the first end of the housing when the inner absorbent member is axially compressed (see Fig. 39 – Solomon).
Regarding Claim 17, Gardner, as modified by Solomon, discloses the seal comprises at least one of holes, cut-away portions, grooves, slits, or slots for permitting the cleaning solution to move past the seal towards the open first end of the housing (see 2294 – Solomon).
Regarding Claim 18, Gardner, as modified by Solomon, discloses a layer of the cleaning solution is provided over a top surface of the seal (see Fig. 39 – at 2258 – Solomon).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0302997 (“Gardner”) in view of U.S. Publication No. 2010/0049170 (“Soloman”) and U.S. Publication No. 2010/0050351 (“Colantonio”) as applied above, and further in view of U.S. Publication No. 2010/0003067 (“Shaw”).
Regarding Claim 5, Gardner appears to disclose an inner surface of the sidewall of the housing comprises an inwardly sloping tapered portion, and wherein an outer surface of the outer absorbent support comprises an angled portion matching the tapered portion of the sidewall (see Fig. 5; see also Fig. 1), although this taper is not explicitly discussed. However, Shaw discloses a related cap (see e.g. 60) with a specifically, inwardly sloping tapered sidewall portion and matching taper to an outer surface of an outer absorbent support (see Fig. 16 – Par. 15). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the cap of Gardner to be tapered, as disclosed by Shaw, in order to assist in insertion of the male connector into the mouth of a cap by ensuring that the mouth of the cap is wider.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0302997 (“Gardner”) in view of U.S. Publication No. 2010/0049170 (“Soloman”) and U.S. Publication No. 2010/0050351 (“Colantonio”) as applied above, and further in view of U.S. Publication No. 2019/0351212 (“Dudar”).
Regarding Claims 6-8, Gardner discloses that the housing comprises a first part (128, see also generally 28 for complete understanding of shared features) which comprises the open first end of the housing formed of a thermoplastic elastomer material, re: a flexible material” (Par. 40). Gardner discloses the invention substantially as claimed except that that the housing further comprises a “second part” (e.g. a knob), which comprises the closed second end of the housing, which can be grasped by the housing, being formed of a rigid thermoplastic material, e.g. a polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. However, Dudar discloses a related cap (100b) which is formed of two distinct materials such that an open first end (110, Fig. 3C) is formed of a more flexible material allowing the open end to better engage the geometry of the inserted connector and a second material (102, 114) inclusive to a knob extending from the second end of the housing may be formed of a more rigid material for grasping the housing (Par. 63), whereby such more rigid materials may be identified as high-density polyethylene (HPDE) or acrylonitrile butadiene styrene (ABS) (Par. 56, 71). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the cap of Gardner with a second, closed end of the cap to include a knob structure formed as a second part of a more rigid material including HDPE or ABS, as disclosed by Dudar, in order to provide an improved gripping surface for affixing the cap and connector together.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0302997 (“Gardner”) in view of U.S. Publication No. 2010/0049170 (“Soloman”) and U.S. Publication No. 2010/0050351 (“Colantonio”) as applied above, and further in view of U.S. Publication No. 2008/0019889 (“Rogers”).
Regarding Claim 21, Gardner discloses the sidewall of the socket is in abutting contact with an inner surface (i.e. the end wall surface) of the outer absorbent support. However, should Applicant argue that because the inner support member and the outer support member are integrally formed that this integral contact cannot be considered “abutting contact” the following is presented. It has been held that constructing a formerly integral structure as a plurality of separable components which are later affixed together is obvious, requiring only routine and customary skill in the art, see Nerwin v. Erlichman 168 USPQ 177, 179. See, generally, for example where Gardner discloses a center insert (211) can either be made integral with the cap (Fig. 6) or can be made separate from the cap (Fig. 7), wherein consideration can equally be made with respect to the making the outer support separate from then inner socket as an obvious design choice. See also Rogers where a center, inner cleaning insert (8) is separately formed from a first outer cleaning insert (7) in a related cleaning cap (10) to predictable and expected results.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive or are moot in view of the new ground(s) of rejection.
Applicant argues (Pg. 8) that “[modifications to Gardner in view of Solomon] would fundamentally change how Gardner’s cap (30) cleans the luer connector…” However, this is not persuasive. The mechanism of action by which Gardner, as modified by Solomon, would clean the cap is preserved and utilizes the same base principles as collected in the various alternative embodiments of Gardner. Gardner discloses that inserts (211, 311…etc.) can be received within the socket, the inserts either storing additional antiseptic agent (211 – Par. 51) or provided without an antiseptic agent in order to seal the lumen of the connector (311 – Par. 56). Gardner also discloses other embodiments wherein the socket (711) is provided in communication with a reserve of antiseptic provided on a compressible, inner absorbent support (725) such that it may be compressed to provide wetting to the socket (Par. 72). As such, modification of Gardner, in view of Solomon, as suggested to provide a sealing absorbent support which is used to seal the lumen of the connector and can be used to compress an inner absorbent support to release a supply of antiseptic for distribution about the socket, but not in the inner lumen of the connector relies upon concepts and features already individually suggested by Gardner. Resolving this combination of features in an expected and predictable manner, in view of Solomon, is obvious in order to ensure that a sufficient volume of antiseptic agent is provided to the device and thereby ensure that complete and adequate distribution of antiseptic about the various surfaces of the received connector (aside from the sealed central lumen) is achieved.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/29/2026
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